Current research activity

Weight Loss / Cardiovascular Risk Reduction

 SURMOUNT-MMO GLP1-RA for weight loss in patients without diabetes and increased cardiovascular risk. Enrollment closing Nov 2023.

 TRIUMPH-OUTCOMES GLP "triple agonist" trial for diabetetics and non-diabetics for cardiovascular risk and weight reduction. Enrollment April 2024

 AFRICAN AMERICAN HEART STUDY registry run by Asscoiatation of Black Cardiologists studying Lp(a) and CV outcomes in the AA community.

Coronary Artery Disease/Dyslipidemia Trials

 Evolve-MI (Amgen) Phase IV • Evolucumab + statin vs standard of care early after MI (STEMI/ACS NSTEMI). Open label

 Librexia-ACS Phase III • Milvexian (FXIa inhibitor) vs. apixaban for patients with STEMI/Non-STEMI ACS.

 PREVAIL (New Amsterdam Pharma) Phase III • Obicetrapib (CETP inhibitor) vs placebo PO Daily for patients with ASCVD and LDL chol >70

 PREVENT (Novartis) Phase III •Phase III • Inclisiran (siRNA, PCSK9 inhibitor) vs. Placebo on top of maximal therapy; examining outcomes in high risk patients

 Oceans(a) (Amgen) Phase III • Olparsiran vs standard of care early after treatment of Lipoprotein a (Lp(a)) in patgients with h/o MI or high risk patietns after PCI. Double blind placebo controlled study. Enrollment closing mid Nov 2023.

 ORION-4 (Novartis)- Phase III • Inclisiran (siRNA, PCSK9 inhibitor) vs. Placebo; examining outcomes in subjects with heart attack or stroke

 VICTORION-INITIATE (Novartis)- Phase III • (*no longer enrolling*) Inclisiran (siRNA, PCSK9 inhibitor) vs. Usual Care; assessing an “inclisiran-first” strategy in an ASCVD population C

Arrhythmia Trials

 OCEANIC-AF (Bayer) Phase III • Asundexian (FXIa inhibitor) vs. apixaban for patients with atrial fibrillation.

 Librexia-AF Phase III • Milvexian (FXIa inhibitor) vs. apixaban for patients with atrial fibrillation.

 AZALEA (Anthos/TIMI)- Phase III • Abelacimab (subcutaneous monoclonal antibody) vs. Rivaroxaban; assessing the bleeding profile of abelacimab in patients with AF with moderate-to-high risk of stroke o Paroxysmal Supraventricular Tachycardia. CLOSED EARLY DUE TO EFFICACY!

 LILAC (Anthos/TIMI)- Phase III (*no longer enrolling*) • Abelacimab (subcutaneous monoclonal antibody) in patients who cannot tolerate anti-coagulation. Enrolling now.

Aortic Valve Regurgitation & Stenosis Trials

 Expand TAVR II (Medtronic) • Evolut™ PRO and Evolut™ PRO+ Device in patients with moderate AS and Class II-III heart failure.

 Optimize PRO (Medtronic) • (*no longer enrolling*) Evolut™ PRO and Evolut™ PRO+ Device Trial examining valve performance & procedural outcomes associated with an “optimized” TAVR (transcatheter aortic valve replacement) care pathway & post-TAVR conduction disturbance pathway

Mitral Regurgitation & Stenosis Trials

 EXPAND G4 (Abbott) (*no longer enrolling*) • MitraClip device trial evaluating outcomes & characterizing trends in patient selection

Heart Failure Trials

 HERMES (Novo Nordisk)- Phase III • Ziltivekimab IL-6 blocking agent vs. Placebo in patients with chronic heart failure with preserved ejection fraction and elevated hs-CRP

 GPID SUMMIT (Eli Lilly)- Phase III • Tirzepatide (GIP & GLP-1 agonist) vs. Placebo in obese patients with chronic heart failure with preserved ejection fraction

Hypertension Trials

 RADIANCE II (Recor) • Paradise System device trial examining the effects of ultrasound renal denervation in subjects with medication-resistant hypertension

The Research Division of Cardiology Assoc. of Fairfield County